Status:
COMPLETED
Efficacy and Safety Study of Non-percutaneous Vertebroplasty With Macroporous Calcium Phosphate Cement (MCPC)
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Vertebra Trauma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo mechanical constraints. ...
Detailed Description
The macroporous calcium phosphate cement, MCPC, which composition is closer to bone than acrylic cement, is malleable and biocompatible, and has intrinsic radio opacity and good biomechanical properti...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 65 years old, BMI \< 30
- Stable and important fracture of the vertebral body between T9 and L5
- Diagnostic maximum 3 weeks after the trauma causing the fracture
- Type A1 to A3 (MAGERL scale) assessed by CT scan
- Lumbar local traumatic angle \> 10°, and thoracic \> 15°
- Given informed consent
- Patient with French health system
Exclusion
- For women: no efficient contraception (intra uterine device, or contraceptive pill)
- Pregnant or feeding women
- Fractures due to metastasis or multiple myeloma
- Symptomatic compression of the spinal cord
- Multi site vertebroplasty
- Scoliosis with a Cobb angle \> 20°
- Surgery zone local infection
- All surgical contraindications
- Immune system abnormalities, immune deficiency or suppression, HIV or BHV or CHV (positive serology)
- Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml
- Uncontrolled diabetes (untreated or non stabilized by treatment)
- Long corticoid treatment (more than 6 months and stopped since less than 3 months)
- Chemotherapy
- All contra indication to MCPC: osteomyelitis, bone degenerative disease or necrosis of surgery site.
- Known allergy to indigotine
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00931333
Start Date
July 1 2009
End Date
February 1 2011
Last Update
November 24 2011
Active Locations (1)
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1
Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin
Bordeaux, France, 33076